ABOUT KITOV

Kitov Pharma is a clinical-stage company that advances first-in-class therapies to overcome tumor-immune evasion and drug resistance in order to create successful, long-lasting treatments for patients with hard-to-treat cancers.

Kitov’s oncology pipeline comprises two drugs. NT-219 is a potential first-in-class small molecule bi-specific inhibitor of two key cancer resistance pathways – STAT3 and IRS1/2. CM-24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor-immune evasion and survival through multiple pathways.

Prior to focusing on oncology, Kitov developed Consensi™, a fixed-dose combination of celecoxib and amlodipine besylate for the simultaneous treatment of osteoarthritis pain and hypertension. The drug was approved by the US Food and Drug Administration (FDA) for marketing in the US in 2018. Consensi is expected to be launched in Q4 2019 [update] by Kitov’s partner Coeptis Pharmaceuticals. Kitov is also partnering with drug firms to commercialize Consensi in China and South Korea.

CM-24

CM-24 is a clinical-stage monoclonal antibody blocking CEACAM1, a novel immune checkpoint expressed in multiple tumor types that supports tumor evasion by the immune system through multiple pathways.

The drug is being developed as a combination therapy with anti-PD1 checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). Kitov plans to initiate Phase 1/2 clinical trials to evaluate the combination of CM-24 with Bristol Myers Squibb’s PD-1 inhibitor nivolumab (Opdivo®) in early 2020. [update]

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NT-219

NT-219 is a potential first-in-class small molecule bi-specific inhibitor of two key cancer resistance pathways – STAT3 and IRS1/2.

Kitov plans to submit an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a clinical study of NT-219 by the end of 2019 [update]. The study will look at NT-219 in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Kitov plans to initiate the trial immediately after FDA clearance.

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ConsensiTM

Consensi™ is a fixed-dose combination of celecoxib (Celebrex), a non-steroidal anti-inflammatory drug (NSAID) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc), a drug designed to treat hypertension.

The FDA approved Consensi oral tablets for marketing in 2018. Kitov’s US marketing and distribution partner, Coeptis Pharmaceuticals, is expected to launch Consensi in Q4 2019 [update]. Kitov is also partnering with drug firms to commercialize Consensi in China and South Korea.

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CONTACT US
One Azrieli Center
Round Tower, Floor 19
132 Menachem Begin Road
Tel Aviv 670110 Israel
Tel. 972 3 9333121
Fax. 972 3 5097196
ir@kitovpharma.com

About
Overview

Kitov Pharma is a clinical-stage company that advances first-in-class therapies to overcome tumor immune evasion and drug resistance.

Founded in 2010, the company initially focused on ConsensiTM, a combination drug indicated to treat osteoarthritis pain and hypertension simultaneously. Kitov became a public company in 2013, trading on the Tel Aviv Stock Exchange (TASE). The company successfully issued an IPO on NASDAQ in November 2015, and is currently traded on both stock exchanges.

The US Food and Drug Administration (FDA) approved Consensi oral tablets for marketing in 2018. Kitov’s U.S marketing and distribution partner, Coeptis Pharmaceuticals, is expected to launch Consensi in Q4 2019 [update]. Kitov is also partnering with drug firms to commercialize Consensi in China and South Korea.

Kitov is currently focused on its oncology portfolio. The first drug is NT-219, a first-in-class small molecule bi-specific inhibitor of two key cancer resistance pathways – STAT3 and IRS1/2. The second is CM-24, a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor-immune evasion and survival through multiple pathways.

Lowering development risk and costs through fast-track regulatory approval of novel therapeutics, Kitov plans to deliver a rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives.

Management Team
Kitov’s management team is comprised of industry veterans with decades of expertise in drug research, development and commercialization – streamlining therapies through clinical trials and regulatory approval for physicians and patients.

Isaac Israel
Chief Executive Officer
Isaac Israel has served as Kitov’s Chief Executive Officer and a member of the board since 2012. Prior to joining Kitov, Mr. Israel founded BeeContact (formerly TASE: BCNT) and served as CEO from 2001 to 2007. Mr. Israel has served as owner and founding CEO of Uneri Capital, a capital market consulting firm specializing in healthcare, since 2008. He serves on the board of various public and private healthcare corporations, including chairman of the board of NextGen Biomed, which is traded on the TASE.

Gil Efron
Deputy CEO and Chief Financial Officer
Gil Efron has served as Kitov’s Chief Financial Officer since 2018. Mr. Efron brings to Kitov over 25 years of experience in financial management. Most recently, he served as Deputy CEO and CFO of Kamada, a NASDAQ and TASE dual-listed plasma-derived protein therapeutics company. Previously, he was CFO of RRsat Global Communications Network, where he led the company’s listing on NASDAQ. Prior to that, Mr. Efron served in various finance-related executive positions. Mr. Efron holds a BA in Economics and Accounting and an MBA from the Hebrew University of Jerusalem, and is a licensed CPA in Israel.

Dr. Gil Ben-Menachem – MSc, MBA, PhD
Vice President – Business Development
Dr. Gil Ben-Menachem has served as Kitov’s Vice President Business Development since 2016. Dr. Ben-Menachem has over 15 years of experience in the pharmaceutical, biotechnology, and venture capital industries. Most recently, he served as Head of Innovative Products at Dexcel Pharma, Israel’s second-largest pharmaceutical company. Prior to that, Dr. Ben-Menachem served as Director of Business Development at Teva Pharmaceutical Industries, where he was responsible for business development efforts in connection with partnering and acquisition deals for late-stage innovative drug candidates. He also served as CEO of OphthaliX, a company that developed drugs in the ophthalmology space, and Director of Business Development at Paramount Biosciences, a New York-based merchant bank and biotechnology venture capital firm. Dr. Ben-Menachem received his PhD from the Hebrew University and an MBA from the University of Maryland. He concluded his postdoctoral training in immunology and microbiology at the National Institutes of Health.

Hadas Reuveni – PhD
Vice President – Research and Development
Dr. Hadas Reuveni has served as Kitov’s Vice President Research and Development since [add year]. Prior to joining Kitov, she co-invented the technology of TyrNovo, a biotech startup company. Dr. Reuveni has been engaged with the scientific projects in TyrNovo’s portfolio since 2005, and has nearly two decades of research and development experience in biotechnology. Dr. Reuveni founded and served as CEO of TyrNovo’s predecessor, NovoTyr, which developed small molecules for the treatment of cancer and neurodegenerative diseases. She also founded and served as a Director and Chief Science Officer of AngioB, a startup that developed GPCR-based agents for multiple indications, from 2006 to 2010. Prior to that, she was the Director of Research & Development at Keryx Biopharmaceuticals (NASDAQ: KRX) from 2001 to 2004. Dr. Reuveni also served as a scientific consultant for Integra Holdings, Campus Bio Management, and BioLineRX (NASDAQ/TASE: BLRX). Dr. Reuveni received her PhD from The Hebrew University of Jerusalem.

 

Pipeline
Overview

Kitov’s development and commercialization pipeline includes two oncology therapies and the company’s first FDA-approved product, Consensi™. Consensi is expected to be launched at the end of 2019 [update] in the US by Kitov’s partner, Coeptis Pharmaceutics.

Consensi™ – fixed-dose combination of celecoxib and amlodipine besylate for the simultaneous treatment of osteoarthritis pain and hypertension that was approved by the FDA for marketing in the US in 2018. Consensi is expected to be launched in Q4 2019 [update] by Kitov’s partner, Coeptis Pharmaceuticals.

CM-24 – clinical-stage monoclonal antibody blocking CEACAM1, a novel immune checkpoint expressed in multiple tumor types that supports tumor evasion and survival through multiple pathways.

NT-219 – potential first-in-class, small molecule bi-specific inhibitor of two key cancer resistance pathways – STAT3 and IRS1/2.

Pipeline
CM-24

CM-24 is a clinical-stage monoclonal antibody antagonist of CEACAM1, a novel immune checkpoint that supports tumor-immune evasion and survival through multiple pathways.

CM-24 is being developed as a combination therapy with anti-PD1 checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). Kitov plans to initiate Phase 1/2 clinical trials to evaluate the combination of CM-24 with Bristol Myers Squibb’s PD-1 inhibitor nivolumab (Opdivo®) in early 2020. [update]

Preclinical studies provide strong justification for CM-24’s mechanism of action in activating the immune system through multiple pathways., CM-24 was found to be well tolerated in a Phase 1 study with doses up to 10mg/kg. Analysis of the Phase 1 data suggested that CEACAM-1 receptor saturation requires a higher dose of CM-24, which is expected be achieved with less than 20mg/kg if administrated every two weeks. The combination of CM-24 with Opdivo® twice-a-week administration protocol could potentially have advantages over existing treatments with three times a week administration protocol.

Kitov is currently under contract to acquire 100% of FameWave Ltd., which owns CM-24.

[Consider adding mechanism of action medical illustration]

NT-219

NT-219 is a first-in-class small molecule bi-specific inhibitor of two key cancer resistance pathways – STAT3 and IRS1/2. The drug has the potential to prevent and overcome drug resistance in various cancer types when used in combination with existing agents. By blocking these tumor progression and resistance pathways, Kitov’s candidates have the potential to restore drug sensitivity and promote anti-tumor drug response in a variety of resistant tumors.

In preclinical models, NT-219 demonstrated outstanding efficacy in preventing acquired resistance and reversing tumor resistance for a variety of approved cancer therapies. These include EGFR antibodies (Erbitux®), small molecular inhibitors of MEK (Mekinist®), mutated BRAF (Zelboraf®), EGFR (Tagrisso®, Tarceva®), and mTOR (Afinitor®), as well as chemotherapy agents such as Gemcitabine, Oxaliplatin, and Docetaxel. Preliminary synergistic effects were also observed in combination with immune oncology agents such as Keytruda®. Preclinical data has also shown that short exposure of cancerous cells to NT-219 is sufficient to trigger an irreversible shutdown of cancer pathways, resulting in a long-term anti-cancer effect. [need ref.]

Kitov plans to submit an Investigational New Drug Application (IND) to the FDA for a clinical study of NT-219 in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck in Q1 2020. [update] The company plans to initiate the trial immediately after the FDA clearance.

[Consider adding mechanism of action medical illustration]

Consensi™

Consensi™ is a fixed-dose combination of celecoxib (Celebrex), a non-steroidal anti-inflammatory drug (NSAID) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc), a drug designed to treat hypertension.

The FDA approved Consensi oral tablets for marketing in 2018. Kitov’s US marketing and distribution partner, Coeptis Pharmaceuticals, is expected to launch Consensi in Q4 2019 [update]. Kitov is also partnering with drug firms to commercialize Consensi in China and South Korea.

Consensi is under patent protection in the US until 2030, and is the only NSAID whose labeling indicates a reduction of blood pressure and consequent risk reduction of heart attack, stroke, and death.